Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROCHLOROTHIAZIDE; VALSARTAN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
HYDROCHLOROTHIAZIDE; VALSARTAN
28Tablet Tablets; 7Tablet Tablets; 14Tablet Tablets
NOVARTIS FARMA S.P.A.
_Consumer Medication Information Leaflet (RiMUP)_ CO-DIOVAN ® FILM-COATED TABLET Valsartan/Hydrochlorothiazide(80/12.5 mg, 160/12.5 mg, 160/25mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Co-Diovan is used for 2. How Co-Diovan works 3. Before you use Co-Diovan 4. How to use Co-Diovan 5. While you are using Co-Diovan 6. Side effects 7. Storage and Disposal of Co-Diovan 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CO-DIOVAN IS USED FOR Co-Diovan contains an angiotensin-II receptor antagonist and a diuretic, which help control high blood pressure. Co-Diovan is used to treat high blood pressure. High blood pressure increases the workload of the heart and arteries (blood vessels). If it continues for a long time, it can damage the blood vessels of the brain, heart, kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders. HOW CO-DIOVAN WORKS Angiotensin II is a natural substance in the body that causes blood vessels to tighten, thus causing your blood pressure to increase. Valsartan in Co-Diovan blocks the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Diuretics reduce the amount of salt and water in the body by increasing the flow of urine. With longer use this helps to reduce and control blood pressure. If you have any questions about how Co- Diovan works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE CO-DIOVAN You may take Co-Diovan only after a medical examination. Co-Diovan may not be suitable for all patients. Follow your doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _When you must not use it _ • If you have had any unusual or allergic reaction to valsartan or to hydrochlorothiazide or sulfonamides or to any other component of this product listed at the end of this leafle Lue koko asiakirja
Novartis Page 2 Malaysia Package Leaflet 01-Feb-2021 Co-Diovan ® CO-DIOVAN Angiotensin II antagonists combination (valsartan) with diuretics (hydrochlorothiazide) DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablets (FCT) 80/12.5 mg, 160/12.5 mg, 160/25 mg Co-Diovan 80/12.5 mg: Ovaloid slightly convex, non-divisible, film-coated tablets measuring approximately 10.2 mm in length and approximately 5.4 mm in width, and weighing approximately 156 mg. The tablets are colored light orange and debossed “HGH” on one side and “CG” on the other side. Co-Diovan 160/12.5 mg: Ovaloid slightly convex, non-divisible, film-coated tablets measuring approximately 15.2 mm in length and approximately 6.2 mm in width, and weighing approximately 312 mg. The tablets are colored dark red and debossed “HHH” on one side and “CG” on the other side. Co-Diovan 160/25 mg: Ovaloid slightly convex, non-divisible, film-coated tablets measuring approximately 14.2 mm in length and approximately 5.7 mm in width, and weighing approximately 310 mg. The tablets are colored brown-orange and debossed “HXH” on one side and “NVR” on the other side. Co-Diovan FCT cannot be divided into equal doses. ACTIVE SUBSTANCES One tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide, or 160 mg valsartan and 12.5 mg hydrochlorothiazide, or 160 mg valsartan and 25 mg hydrochlorothiazide Certain dosage strengths and dosage forms may not be available in all countries. EXCIPIENTS Co-Diovan 80/12.5 mg: Colloidal silicon dioxide; crospovidone; hydroxypropyl methylcellulose; magnesium stearate; microcrystalline cellulose; polyethylene glycol; talc; titanium dioxide (E171); red iron oxide (E172); yellow iron oxide (E172). Co-Diovan 160/12.5 mg: Colloidal silicon dioxide; crospovidone; hydroxypropyl- methylcellulose; magnesium stearate; microcrystalline cellulose; polyethylene glycol; talc; titanium dioxide (E171); red iron oxide (E172). Co-Diovan 160/25 mg: Colloidal silicon dioxide; crospovidone; hydroxypropyl methylcell Lue koko asiakirja